Dynamic integrated lancing test strip with sterility cover

ABSTRACT

An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/070,502 filed Mar. 2, 2005, which is hereby incorporated byreference.

BACKGROUND

The present invention generally relates to bodily fluid sampling devicesand more specifically, but not exclusively, concerns an integratedlancing test strip with a lancet contained within a sterility sheet.

The acquisition and testing of bodily fluids is useful for manypurposes, and continues to grow in importance for use in medicaldiagnosis and treatment, such as for diabetes, and in other diverseapplications. In the medical field, it is desirable for lay operators toperform tests routinely, quickly and reproducibly outside of alaboratory setting, with rapid results and a readout of the resultingtest information. Testing can be performed on various bodily fluids, andfor certain applications, is particularly related to the testing ofblood and/or interstitial fluid. Performing home based testing can bedifficult for many patients, especially for patients with limited handdexterity, such as the elderly or diabetics. For example, diabetics cansometimes experience numbness or tingling in their extremities, such astheir hands, which can make self-testing difficult because they areunable to accurately position a test strip to collect the blood sample.In addition, wounds for diabetics tend to heal more slowly, and as aresult, there is a desire to make incisions less invasive.

Recently, integrated lancing test strips have been developed in which atest strip is integrated with a lancet so as to form a single disposableunit. While these integrated units have somewhat simplified thecollection and testing of fluid samples, there are still a number ofissues that need to be resolved before a commercial unit can beimplemented. One issue concerns maintaining the sterility of the lancetso as to minimize the risk of infection. In practice, conventionalplastic or syringe type caps that are used to maintain the sterility oftypical lancets cannot be incorporated with integrated lancing teststrips for several reasons, especially for those designs with lancetsthat are moveable relative to the rest of the test strip. With typicalsyringe type caps, the cap encapsulates the lancet, and the cap isremoved by pulling or twisting the cap off the lancet. However, theremoval of the cap from the lancet without destroying or damaging theintegrated device is difficult or even practically impossible. Moreover,automatic cap removal with such caps can be difficult. There is a trendto make lancets smaller or thinner so as to make less traumatic or lessinvasive incisions, which in turn makes self-monitoring less painful aswell as promotes healing of the incision. However, due to their thinnernature, lancets are more prone to bending or are susceptible to otherdamage, especially when protective caps are removed. Further, thepulling or twisting action during cap removal can damage the test strip,like delicate electrodes in electrochemical type test strip, or can evenresult in the lancet being separated from the test strip.

Integrated devices have been proposed in which the lancet isencapsulated within a sterilized plastic body or a molded plastic plugthat encloses one end of a lancet chamber. During lancing, the lancetpierces the body so as to extend from the body and lance the tissue.Such a design is suitable for automated systems because the lancet canbe fired without the need to remove a protective cap. Given their bulkyand rigid nature, these types of designs are not well suited formagazines, drums, cassettes, cartridges and the like, however. Theencapsulating plastic creates a rather large profile, which does notallow a plurality of integrated devices to be packed in a tight package.Due to the somewhat rigid nature of the encapsulating material, thedevices are too rigid by themselves for integration into a reel-to-reeltype cassette design. Moreover, the injection molding required tomanufacture these types of integrated devices can make the devicesconsiderably more expensive as well as more difficult to assemble. Suchdesigns can also limit how small the lancet can be because the lancethas to be rigid enough to still be able to puncture the seal.

Other integrated disposable designs have been proposed in which theentire unit is sealed within a protective packet. However, these designsrequire the entire disposable unit to be sterilized at the same time,which results in a whole host of difficulties. Unfortunately,sterilization techniques for lancets, such as radiation, adverselyaffect the chemical enzymes of the test strip. Hence, if leftuncompensated, the accuracy of the test strip can be significantlyhampered. To compensate for the changes that occur during sterilization,samples from sterilized lots are taken so that an adjustment orcalibration value can be calculated for the lot. Before use, thecalibration value for the lot is entered, either manually orautomatically, into the meter to compensate for lot variations.Moreover, certain desirable sterilization techniques for lancets areimpractical when the lancet and test strip are combined together becausethese techniques tend to damage or even destroy components on the teststrip. In addition, undesirable cross contamination can occur betweenthe lancet and the test strip when sealed in the same protective packet.For instance, components of the test strip, such as chemicals,biological components, adhesives and the like, can migrate within thepacket onto the lancet, thereby possibly compromising the sterility ofthe lancet.

Ensuring that a sufficient amount of body fluid is collected duringsampling is another issue that needs to be addressed before a viablecommercial integrated lancing test strip can be implemented. It isdesirable that the integrated device only lightly contacts the skinduring fluid sampling. If the integrated device is pressed too hardagainst the skin, fluid flow from the incision can be blocked, which canoccasionally lead to insufficient sample sizes. However, if the teststrip is not touching at all, the test strip may be too far away for theblood drop to reach the capillary entrance of the test strip. When aninsufficient amount of fluid for testing is collected, usually theintegrated device has to be disposed of, and a new one is used toperform the test again. Further complicating this problem is that theelasticity of skin varies from person to person as well as variesbetween different body parts on the individual, which can createdifficulties in locating the test strip. For example, the skin of achild is more elastic than that of the elderly. As a sampling device ispressed against the skin, the more elastic skin of the child tends tobow or pucker to a greater degree than the inelastic skin of theelderly. This variation of skin puckering height between individuals andbody locations makes it difficult to design a meter that can accuratelyposition a test strip so as to not contact the skin or only slightlycontact the skin so as to not disturb fluid flow, but still be able tocontact the drop of fluid from the incision for fluid collectionpurposes.

Thus, needs remain for further contributions in this area of technology.

SUMMARY

One aspect concerns an integrated lancing test strip that includes atest strip adapted to analyze body fluid and a packet coupled to thetest strip. The packet includes an incision forming member to form anincision in tissue. A sterility sheet covers the packet to maintainsterility of the incision forming member and preventscross-contamination between the test strip and the incision formingmember. The sterility sheet allows the incision forming member to besterilized separately from the test strip.

Another aspect concerns a technique in which a lancet packet is createdby enclosing a lancet in a sterility sheet to form a sterile enclosure.The lancet is sterilized, and the integrated lancing test strip isassembled by attaching the lancet packet to a test strip aftersterilizing the lancet.

A further aspect relates to a meter that includes a holder that isconfigured to hold a test strip. An adjustment mechanism cooperates withthe holder to position the test strip relative to a tissue with anincision for reducing pressure applied against the tissue. By reducingthe pressure applied against the tissue, flow constriction of body fluidfrom the incision is minimized as the body fluid is collected with thetest strip.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a first top exploded view of an integrated lancing test stripaccording to one embodiment.

FIG. 2 is a second top exploded view of the FIG. 1 integrated lancingtest strip.

FIG. 3 is a third top exploded view of the FIG. 1 integrated lancingtest strip.

FIG. 4 is a top perspective view of the FIG. 1 integrated lancing teststrip with its lancet in an extended position.

FIG. 5 is a bottom exploded view of the FIG. 1 integrated lancing teststrip.

FIG. 6 is a first bottom perspective view of the FIG. 1 integratedlancing test strip with the lancet in a retracted position.

FIG. 7 is a second bottom perspective view of the FIG. 1 integratedlancing test strip with the lancet in the extended position.

FIG. 8 is a first front perspective view of a meter when the FIG. 1integrated lancing test strip is loaded.

FIG. 9 is a second front perspective view of the FIG. 8 meter duringloading of the FIG. 1 integrated lancing test strip.

FIG. 10 is a rear perspective view of the FIG. 8 meter.

FIG. 11 is a perspective view of the FIG. 8 meter with its housingremoved.

FIG. 12 is a cross-sectional view of the FIG. 8 meter.

FIG. 13 is an enlarged cross-sectional view of an actuation mechanism inthe FIG. 8 meter.

FIG. 14 is a perspective view of the FIG. 8 meter as the FIG. 1integrated lancing test strip is loaded.

FIG. 15 is a perspective view of a cam arm of the FIG. 8 meter engagingthe FIG. 1 integrated lancing test strip.

FIG. 16 is a perspective view of the FIG. 8 meter and the FIG. 1integrated lancing test strip prior to lancing.

FIG. 17 is a perspective view of the FIG. 8 meter and the FIG. 1integrated lancing test strip during lancing.

FIG. 18 is a perspective view of the FIG. 8 meter and the FIG. 1integrated lancing test strip during sampling.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates. One embodiment of the invention is shown indetail, although it will be apparent to those skilled in the relevantart that some features that are not relevant to the present inventionmay not be shown for the sake of clarity.

One of the many embodiments of the present invention concerns anintegrated lancing test strip that includes a unique sterility enclosuresystem. The integrated lancing test strip includes a lancet for formingan incision that is attached to a test strip for analyzing fluid fromthe incision. The lancet is at least partially enclosed by a sterilitysheet, which maintains sterility of the lancet and simplifiesmanufacturing of the integrated lancing test strip. By enclosing thelancet in the sterility sheet, the lancet can be sterilized separatelyfrom the test strip, and then attached to the test strip aftersterilization. As a result, this separate or modular construction oflancet and test strip allows the lancet to be sterilized withoutadversely effecting on chemical enzymes in the test strip that wouldaffect the accuracy of the test results. With the sterility sheet, theintegrated lancing test strip can also have a compact profile, which iswell suited for incorporation of multiple integrated lancing test stripsinto magazines, drums, cassettes, cartridges and the like. Further, thesterility sheet minimizes cross-contamination between the lancet and thetest strip before, during and after use. In one form, the integratedlancing test strip is loaded into a lancing device or meter that isconfigured to fire the lancet. The meter includes an adjustmentmechanism that allows the user to adjust the position of the test striprelative to the skin during sampling. The adjustment mechanism allowsusers to compensate for a number factors, such as variations in skinelasticity, skin type, body part size and the pressure applied, to namea few. The adjustment mechanism can be used to compensate for thesedifferent conditions so as to allow the test strip to be positionedclose enough to collect a fluid sample, but not too close so as tohinder fluid flow from the wound.

An integrated lancing test strip or device 20 according to oneembodiment, among many, of the present invention will be describedinitially with reference to FIGS. 1, 2, 3, 4, 5 and 6. Referring to FIG.1, the integrated lancing test strip 20 includes a lancet assembly orincision forming member 22 for forming an incision in tissue, asterility sheet or foil 24 for maintaining the sterility of the lancet22, and a test strip 26 for acquiring a body fluid from the incision.Both the lancet 22 and the test strip 26 in the illustrated embodimentare generally flat such that the integrated lancing test strip 20 has anoverall flat appearance. By being flat, multiple integrated lancing teststrips 20 can be incorporated into magazines, cassettes, drums,cartridges and the like, which allows a plurality of integrated lancingtest strips 20 to be used without the need to individually load and/ordispose of used integrated devices 20. For example, the overall flatshape allows multiple integrated lancing test strips 20 to be stackedupon one another in a magazine or rolled around a reel in a cassette.Furthermore, the overall flat shape allows the integrated lancing teststrip 20 to be manufactured with a continuous process in which layers ofcomponent materials can be layered to form contiguous strips ofintegrated lancing test strips 20 that can be cut to form individualunits or remain attached for use in cassettes and the like. It shouldnonetheless be recognized that the integrated lancing test strip 20 inother embodiments can have a different overall shape.

As can be seen in FIGS. 1 and 5, the lancet assembly 22 has a retainingelement or guide member 28 that guides a piercing member or lancet 30during lancing. The lancet 30 is slidably retained within a guide slotor opening 31 that is defined in a retainer 28. In the course oflancing, the guide slot 31 guides the movement of the lancet 30 duringboth extension and retraction. In the illustrated embodiment, the lancet30 and the retainer 28 are separate components that are not directlyattached to one another. Nevertheless, in other embodiments, the lancet30 and the retainer 28 can be connected to one another. For example, thelancet assembly 22 can have breakable tabs that connect the lancet 30 tothe retainer 28 so that the lancet 30 is held in place duringmanufacturing as well as prior to lancing, thereby reducing the risk ofinjury. During lancing, the tabs are broken to allow the lancet 30 toextend from the integrated lancing test strip 20. In another example, aspring for retracting the lancet 30 connects the retainer 28 to thelancet 30.

As shown, end stops 32 of the retainer 28 extend inwardly at a slotopening 34 of the guide slot 31 so as to limit the movement of thelancet 30, thereby retaining the lancet 30 in the guide slot 31, as isdepicted in FIG. 7. The lancet 30 has a body portion 35 with one or morestop edges 36, which are wider than the slot opening 34. When the lancet30 is fully extended, the stop edges 36 of the lancet 30 can contact theend stops 32, and thus, limit the travel of the lancet 30. However, inother embodiments, the firing mechanism, which is used to fire thelancet 30, limits the travel of the lancet 30. A neck portion 37 of thelancet 30, which is slightly smaller that the size of the slot opening34, extends from the body portion 35 of the lancet 30. During extensionof the lancet 30, the neck 37 is received between the end stops 32 suchthat the end stops 32 can limit undesirable rotation of the lancet 30 asthe tissue is punctured. Extending from the neck 37, the lancet 30 has ablade portion or tip 38 that is configured to cut tissue. In theillustrated embodiment, the lancet defines an engagement notch 39 forcoupling the lancet 30 to a firing mechanism. In one form, the lancetassembly 22 is made at least in part of medical grade stainless steel,but it should be recognized that the lancet assembly 22 can be made ofother materials, such as ceramics and/or plastics. Furthermore, it iscontemplated that the guide member 28 and the lancet 30 can be made ofdifferent materials and/or manufactured separately. In one embodiment,the guide member 28 and lancet 30 are formed by a photo-etchingtechnique in which a sheet of metal is photo-etched to form both theguide member 28 and the lancet 30, and in another embodiment, the lancetassembly 22 is manufactured via stamping. The lancet assembly 22 instill other embodiments can be manufactured through other techniques aswould occur to those skilled in the art.

With reference to FIGS. 1 and 2, after the lancet assembly 22 is formed,the lancet assembly 22 can be then packaged within the sterility sheet24. As will be appreciated from the discussion below, the lancetassembly 22 can be packaged in the sterility sheet 24 before, during orafter the lancet assembly 22 is sterilized. In the illustratedembodiment, the sterility sheet 24 is a sheet of metallic foil, and inanother embodiment, the sterility sheet 24 is made of plastic. It shouldbe recognized that the sterility sheet 24 can be made of other types ofmaterials. During manufacturing, the sterility sheet 24 is folded intotwo flaps 40 with a crease or fold 42 in between, as is shown in FIG. 1.After folding, the lancet assembly 22 in FIG. 2 is sandwiched betweenthe two folds 40 such that the crease 42 closes the slot opening 34 ofthe guide slot 31. As depicted in FIG. 3, the folds 40 are secured tothe opposite (flat) sides of the lancet assembly 22 so that the lancet30 is sealed inside the guide slot 31 with the slot opening 34 closed bythe crease 42. In one form, an adhesive is used to secure the sterilitysheet to the guide member 28. Adhesive is applied on the guide member 28around the guide slot 31, but is not applied to the lancet 30 so thatthe lancet 30 is able to still slide within the guide slot 31. Althoughan adhesive is used in the illustrated embodiment, it should beunderstood that the sterility sheet 24 can be sealed with the guidemember 28 in other manners, such as through heat sealing. In theillustrated embodiment, the edges of the folds 40 are not sealedtogether, but it is envisioned that in other embodiments the edges ofthe sterility sheet 24 can be sealed together so as to form a pocketthat encloses the entire lancet assembly 22. In still yet anotherembodiment, instead of folding the sterility sheet 24, two sterilitysheets 24 are joined together with the lancet assembly 22 sandwiched inbetween. For the sake of clarity, the drawings only show how anindividual integrated lancing test strip 20 is formed, but it iscontemplated that the integrated lancing test strips 20 in oneembodiment are formed in a continuous process. In the continuousprocess, the sterility sheet 24 is a continuous band that is rolled offa reel and folded around a continuous band or belt of lancet assemblies22 that are likewise rolled from a reel.

Once joined together, the lancet assembly 22 and the sterility sheet 24form a lancet package or packet 44. As mentioned before, the lancetassembly 22 can be sterilized before being enclosed in the sterilitysheet 24. The lancet assembly 22 can be sterilized through any number ofsterilization techniques as would occur to those skilled in the art,such as through chemical, heat, and/or radiation sterilizationtechniques, to name a few. It should be understood that all or part ofthe lancet assembly 22 can be sterilized. For instance, only the lancet30 and guide slot 31 can be sterilized, if so desired. In anotherembodiment, the lancet assembly 22 is sterilized after the lancetassembly 22 is packaged inside the lancet package 44. In one form, aradiation sterilization technique is used once the lancet 30 is enclosedby the sterility sheet 24. With the lancet package 44, sterilization ofthe lancet assembly 22 can occur without exposing the test strip to theundesirable affects of lancet sterilization.

In the illustrated embodiment, the test strip 26 is an electro-chemicaltype test strip. In one particular form, the test strip 26 includes amodified version of an ACCU-CHEK® brand test strip (Roche DiagnosticsGmbH), but it is envisioned that other types of test strips can be used.For example, the test strip 26 in other embodiments can include anoptical type test strip or can analyze fluid samples in other manners.At one end, the test strip 26 in the illustrated embodiment includes aconnection portion 46 with electrical contacts 47 that transmit samplereadings to a meter. Opposite the connection portion 46, the test strip26 has a capillary channel 48 with a capillary opening 49 that isconfigured to draw a body fluid sample from an incision formed by thelancet 30 via capillary action. As should be appreciated, the test strip26 inside the capillary channel 48 includes an analysis region thatincludes electrodes, such as working, counter and reference electrodes,and reagents for analyzing the fluid sample. In one form, the connectionportion 46 is connected to a meter, and the sample readings from theelectrodes in the analysis region are transmitted to the meter via theelectrical contacts.

Looking at FIGS. 5 and 6, the sterilized lancet package 44 is attachedto the test strip 26 to form the integrated lancing test strip 20. Asdepicted, the lancet package 44 is attached at the end of the test strip26 proximal to the capillary opening 49 of the capillary channel 48. Inparticular, the guide slot opening 34 of the lancet assembly 22 and thecapillary opening 49 of the test strip 26 are positioned near oneanother in a side-by-side relationship so that, when the lancet 30 formsthe incision, the capillary channel opening 49 is positioned in closeproximity to collect the body fluid. The test strip 26 is attached tothe exterior of the sterility sheet 24 enclosing the lancing member 22to complete the integrated test strip 20. The test strip 26 in one formis attached to the lancet package 44 through an adhesive, but it shouldbe recognized that the test strip 26 and lancet package 44 can beattached in other manners. In one form, the lancet package 44 isattached to the test strip 26 such that the end edges of both arealigned with another. However, in other embodiments the edges of thelancet package 44 and the test strip 26 can be offset from one another.For example, the edge of the lancet package 44 in the illustratedembodiment, as is demarked by crease 42, is recessed slightly from theedge of the test strip 26 at the capillary opening 49. By having thelancet package 44 recessed, fluid flow to the capillary channel opening49 is promoted. In another example, the sterility sheet 24 is positionedsuch that the crease 42 extends past the edge of the test strip 26. Withthis example, all or part of the sterility sheet 24 can be hydrophobicand/or hydrophilic so as to direct fluid flow towards the capillarychannel 48. In one particular form, the sterility sheet 24 extends fromthe test strip 26 such that the sterility sheet 24 acts like a flexiblewicking flag that draws fluid into the capillary channel 48.

To draw the body fluid towards the capillary channel opening 49 and awayfrom the lancet 30, the test strip 26 in the illustrated embodiment hasa fluid direction notch 50 facing the lancet package 44. In order toenhance fluid flow towards the capillary channel opening 49, thesterility sheet 24 can be treated and/or made to be hydrophobic. Withthe sterility sheet 24 being hydrophobic, the sterility sheet cansqueegee or wipe body fluid from the lancet 30 as the lancet 30 retractsback inside the guide slot 31. It is thought that the wiping action ofthe sterility sheet 24 increases the amount of body fluid available forsampling as well as makes the lancet 30 cleaner for disposal purposes.As noted before, with the lancet 30 sealed in the lancet package 44, therisk of cross-contamination between the lancet 30 and the test strip 26is reduced.

In FIGS. 3 and 4, the test strip 26 further defines a relief slot 51through which a blade tip of a cam arm extends when engaging the lancet30 during loading and firing. In addition, the relief slot 51 can beused to vent air from the capillary channel 48 as fluid is collected.The length of the relief slot 51 generally approximates the length ofthe lancing stroke of the firing mechanism used to actuate the lancet30. When the lancet package 44 is attached to the test strip 26, theengagement notch 39 on the lancet 30 is aligned with the relief slot 51in the test strip 26. As will be described in greater detail below, theblade tip of a cam arm for the firing mechanism extends through theengagement notch 39 of the lancet 30 as well as into the relief slot 51.When doing so, the blade tip pierces the sterility sheet 24. Duringlancing, the cam arm via the blade extends and retracts the lancet 30relative to the test strip 26. As the lancet 30 extends, the tip 38 ofthe lancet 30 pierces the sterility sheet 24 at crease 42, as isillustrated in FIGS. 4 and 7. In one form, the sterility sheet 24 at thecrease 42 is weakened so as to aid in puncturing by the lancet 30, butin other forms, the crease 42 is not weakened. Once the lancet 30 isretracted back inside the guide slot 31, as is shown in FIG. 6, the twoflaps 40 of the sterility sheet 40 can hold the lancet 30 inside throughfriction. By engaging the lancet 30 in such a manner, the risk ofaccidental puncturing by the integrated lancing test strip 22 is reducedbecause it is more difficult to manually and/or accidentally actuate thelancet 30. It should be recognized that the lancet assembly 22 canincorporate other structures for engaging the lancet 30. For instance,the engagement notch 39 in the lancet 30 can be replaced with aprotrusion or knob. It is also contemplated that the lancet can be firedthrough non-mechanical and/or non-contact techniques, which do notrequire the puncturing of the sterility sheet 24. As an example, thelancet 30 in another embodiment is magnetized and fired magneticallythrough a voice coil driver. With the lancet 30 enclosed in thesterility sheet 24 both before and after lancing, the risk ofcontamination is reduced, and the risk of accidental injury is likewisereduced.

A lancing device or meter 60, according to one embodiment, that isconfigured to lance tissue and collect as well as analyze fluid from thetissue with the integrated lancing test strip device 20 is illustratedin FIGS. 8, 9 and 10. In one embodiment, the meter 60 includes a displayor other types of output means for outputting sample readings from theintegrated lancing test strip 20. The meter 60 in the illustratedembodiment is configured to adjust the relative position of the teststrip 26 from the skin during sampling. Referring to FIG. 8, the lancingdevice 60 has a cap portion 62 that is configured to contact tissue anda firing mechanism 63 with a cocking knob 64 for the cocking of thefiring mechanism 63. The lancing device 60 further includes anadjustment control or mechanism 66 for adjusting the sampling positionof the test strip 26 and a housing 68 with an end plate 69 that housesthe components of the lancing device 60. As shown in FIGS. 8 and 9, thecap 62 is hingedly coupled to the housing 68 so that the cap 62 can bepivoted away to permit loading of the integrated lancing test strip 20(FIG. 9). The cap 62 further includes a latch 70 with an opening thatengages a lock tab 71 on the housing 68 such that the cap 62 is lockedin place once the integrated lancing test strip 20 is loaded, as isdepicted in FIG. 8. An expression member 72 is coupled to the cap 62,and the expression member 72 defines a sampling opening 73 through whichthe lancet 30 lances the skin and the test strip 26 collects fluid fromthe incision. In the embodiment shown, the expression member 72 isring-shaped and is threadedly coupled to the cap 62, so that theexpression member 72 is able to move in a telescoping fashion, therebyallowing height adjustment of the expression member 72 relative to thecap 62. The proximity of the test strip 26 to the target tissue can beadjusted by the user, by turning the expression member 72. Thisadjustment can be individually based on a number of factors such as thesize of the body part being sampled and how hard the user typicallypresses against the skin. Around the sampling opening 73, the expressionmember 72 has a skin or tissue contacting surface 74 that is configuredto contact the skin during lancing and sampling. In the illustratedembodiment, the skin contacting surface 74 is inwardly angled so as topromote expression of fluid from the incision as the cap 62 is pressedagainst the skin.

As can be seen in FIG. 10, the firing mechanism 63 includes a firingbutton 76 that is pressed by the user in order to actuate the firingmechanism 63, once cocked. In the illustrated embodiment, the firingmechanism 63 includes a spring-powered type firing mechanism of the typeas generally known to those skilled in the art. To cock the firingmechanism, the cocking knob 64 is pulled and the potential energy frompulling the knob 64 is stored by the springs in the firing mechanism 63.When the user presses the firing button 76, the potential energy storedin the springs is released so that the energy is used to fire the lancet30. After the lancet 30 is fully extended, the firing mechanism 63recoils so as to retract the lancet 30 from the target tissue. It shouldbe recognized that the lancing device 60 can incorporate other types offiring mechanisms as known to those skilled in the art, like electricaland/or pneumatic type firing mechanisms, for example.

FIG. 11 shows the lancing device 60 with the housing 68 partiallyremoved, and FIG. 12 shows a cross-sectional view of the lancing device60. As shown, the firing mechanism 63 extends through and is secured tothe end plate 69 of the housing 68. Opposite the cocking knob 64, thefiring mechanism 63 has an actuation arm 80 that is configured to extendfrom the firing mechanism 63 upon lancing and subsequently retract, asis indicated by double arrow 81. In the illustrated embodiment, theactuation arm 80 is in the form of a rod, but the actuation arm 80 aswell as the rest of the firing mechanism 63 in other embodiments canhave a different shape than is shown. To give the lancing device 60 acompact configuration, the lancing device 60 includes a drive connector82 that is connected to the actuation arm 80 of the firing mechanism 63.The drive connector 82 is configured to transmit force from the firingmechanism 63 to an actuation assembly 84, which physically fires theintegrated lancing test strip 20. In the illustrated embodiment, thedrive connector 82 is L-shaped so that the firing mechanism 63 and theactuation assembly 84 can be oriented in a side-by-side relationship soas to give the lancing device 60 an overall compact shape. The actuationassembly 84 includes a bearing block 87 with a bearing channel 85 thatreceives a bearing rib 86. The bearing block 87 is connected to thedrive connector 82, and the bearing rib 86 is secured to the housing 86via the firing mechanism 63. As the actuation arm 80 of the firingmechanism 63 extends and retracts, the bearing block 87 slides relativeto the bearing rib 86.

With reference to FIGS. 12 and 13, the actuation assembly 84 includes astrip holder 90 for holding and actuating the integrated lancing teststrip 20. The strip holder 90 defines a cam arm channel 92 in which acam arm 94 is pivotally disposed. As depicted, the cam arm 94 ispivotally coupled to the holder 90 via a pivot pin 96, but it should berealized that the cam arm 94 and the holder can be pivotally coupled inother manners. Looking at FIG. 13, the holder 90 further defines a slideconnector arm cavity 98 in which a connector arm 100 is slidablydisposed. Connector arm 100 is connected to a connector block or member102 such that the connector block 100 is able to slide relative to theholder 90. The connector block 102 defines a connector slot 104 that isshaped to receive the connection portion 46 of the test strip 26. Insidethe connector slot 104, the connector block 102 in one form includeselectrical contacts that touch the contacts 47 on the test strip 26 inorder to transmit readings from the test strip 26 to the meter 60.

At one end, the cam arm 94 has a cam member or portion 106 with a camsurface 108 that is angled or tapered to engage the connector block 102.Near the cam portion 106, the cam arm 94 has a limit tab 110 that isconfigured to contact the holder 90 in order to limit the rotation ofthe cam arm 94. Opposite the cam portion 106, the cam arm 94 has alancet engagement blade 112 that is sharp in order to pierce thesterility sheet 24 of the integrated lancing test strip 20. Duringloading of the integrated lancing test strip 20, the connector block 102is pushed further inside the lancing device 60 towards the cam portion106 of the cam arm 104. When the connector block 102 engages the camsurface 108 of the cam portion 106, the cam arm 94 is rotated such thatthe blade 112 punctures the sterility sheet 24. After cutting thesterility sheet 24, the blade 112 extends into the engagement notch 39of the lancet 30 so that the cam arm 94 is able to hold the lancet 30during lancing. The relief notch 51 in the test strip 26 ensures thatthe blade 112 extends completely through the engagement notch 39 so thatthe cam arm 94 fully engages the lancet 30. In the illustratedembodiment, the integrated lancing test strip 20 is loaded with thelancet assembly 28 facing the blade 112 so that the blade 112 firstextends through the engagement notch 39 of the lancet 30 beforeextending through the relief notch 51 of the test strip 26. It iscontemplated that in other embodiments the integrated lancing test strip20 is flipped so as to be oriented in the opposite manner. That is, thetest strip 26 faces the blade 112 during loading so that the bladeengages the lancet 30 by extending first through the relief notch 51 inthe test strip 26. In the illustrated embodiment, the holder 90 has oneor more detent mechanism 114 that engage one or more detent openings 116in the cam arm 94 so as to hold the cam arm 94 in position duringlancing. In one embodiment, the detent mechanism 114 includes aball-type detent, but as should be recognized, other types of mechanismscan be used to hold the cam arm 94 in position. In the illustratedembodiment, the blade 112 is hooked shaped or angled so as to permiteasy removal of the integrated lancing test strip 20 subsequent tosampling and/or testing. Near the blade 112, a cover 118 is secured tothe holder 90. Together, the cover 118 and the holder 90 define a stripholder slot 120 that receives and holds the integrated lancing teststrip 20 during both lancing and sampling. Referring again to FIG. 12,the strip holder slot 120 is aligned with the sampling opening 73 in thecap 70 so that the integrated lancing test strip 20 is able to samplefluid in an unencumbered manner.

As mentioned before, the adjustment control 66 allows for the adjustmentof the position of the test strip 26 relative to the skin duringsampling so that the test strip 26 does not press too hard against theskin so as to constrict bleeding from the incision. As illustrated inFIGS. 11 and 12, the adjustment control 66 is threadedly secured to theend plate 69, and the adjustment control 66 extends through the endplate 69 and engages a limit stop 122, which faces the connector block102. At least a portion of the stop 122 is received in a guide channel124 (FIG. 11) so as to prevent rotation of the stop 122 as theadjustment control 66 is turned. By twisting the adjustment control 66,the distance between the stop 122 and the connector block 102 can beincreased or reduced. During operation, the stop 122 limits the travelof the connector block 102, which in turn limits how far the test strip26 is able to retract away from the target tissue, and hence, controlthe distance between the capillary opening 49 of the test strip 26 andthe surface of the target tissue. As a result, the test strip 26 can bekept in close proximity to the tissue or slightly contact the tissuewithout the risk of hindering blood flow from the wound. It iscontemplated that the adjustment mechanism 66 can includes other typesof adjustment mechanisms. By way of a non-limiting example, theadjustment mechanism in another form can includes an electrical motorthat moves the stop 122. The position of the stop 122 can be adjustedmanually by the user through one or more buttons on the meter 60 or canbe automatically adjusted by the meter 60. In one form, the meter 60automatically adjusts the position of the test strip 26 by sensing therelative position of the skin via a sonar-type detector and/or via anoptical sensor.

The integrated lancing test strip 20 can form an incision and collectbody fluid from the incision using a number of techniques. In onetechnique, the test strip 26 is held fixed in relation to the lancingdevice 60, and the lancet 30 is moved forward and backwards to piercethe skin. In another technique, the lancet 30 is held fixed to the teststrip holder 90 while the test strip 26 can move with the connectorblock 102. When the test strip 26 contacts the skin, the test strip 26is pushed back by the skin such that the lancet 30 is exposed so as topierce the skin or other tissue. With the test strip 26 contacting theskin, variations in skin height do not significantly affect thepenetration depth of the lancet 30.

To aid in understanding and appreciating the features of the integratedlancing test strip 20 and the meter 60, a technique for sampling fluidwill be described with reference to FIGS. 14, 15, 16, 17 and 18. Fromthe previous discussion, it however should be recognized that the bodyfluid can be sampled in other manners. With reference to FIG. 14, theintegrated lancing test strip 20 is loaded by pushing the integratedlancing test strip 20 into the meter 60, as is shown by direction arrow130. The connection portion 46 of the test strip 26 is received in theconnector block 102, as is depicted in FIG. 13. While the integratedlancing test strip 20 is pushed farther inside the meter 60, theconnector block 102 engages the cam surface 108 on the cam arm 94 suchthat the cam arm 94 pivots in a teeter-tooter fashion. The pivoting ofthe cam arm 94 causes the blade 112 on the cam arm 94 to pierce thesterility sheet 24 on the integrated lancing test strip 20 so that theblade 112 engages the engagement notch 39 in the lancet 30, as isdepicted in FIG. 15. Once the cam arm 94 is rotated to engage the lancet30, the detent mechanism 114 locks the position of the cam arm 94 so asto prevent accidental disengagement during lancing. While the integratedlancing test strip 20 is pushed farther inside the meter 60 (FIG. 15),as indicated by direction arrow 130, the blade 112 on the cam arm 94forms a slit 132 in the sterility sheet 24. The slit 132 in thesterility sheet 24 allows for smooth movement of the lancet 30 and camarm 94 during retraction. Once the connector 102 contacts the stop 122,the integrated lancing test strip 20 is fully loaded.

In one embodiment, when the integrated lancing test strip 20 is fullyloaded, the lancet 30 remains completely sealed inside the pouch formedby the sterility sheet 24 until lancing is initiated. In anotherembodiment, like the one shown in FIG. 15, the tip 38 of the lancet 30slightly pierces the crease 42 of the sterility sheet 42 once theintegrated lancing test strip 20 is fully loaded. To prevent accidentalinjury, the tip 38 of the lancet 30 does not however extend past theedge of the test strip 26. During loading of the meter 60, the cap 62 ofthe meter 60 is pivoted out of the way in the manner as is shown in FIG.9. Once loaded, the cap 62 of the meter 60 is rotated and locked into afiring position, like is illustrated in FIG. 8. The firing mechanism 63is cocked by pulling the knob 64. Before lancing is initiated, thesampling opening 73 of the cap 62 is positioned over a targeted bodypart or tissue 134, such as the skin of a finger, which is shown in FIG.16, so that the expression member 72 contacts the body part 134. Itshould be recognized that the firing mechanism 63 can be cocked beforeor after the meter 60 is placed against the targeted body part 134.

Referring to FIGS. 10, 12 and 17, the user presses the fire button 76 ofthe firing mechanism 63 to initiate lancing. Upon firing, the actuationarm 80 (FIG. 12) extends from the firing mechanism 63, and the driveconnector 82 transmits this extension force to the holder 90, wherebythe holder 90 likewise moves towards the body part 134. As the holder 90moves, the integrated lancing test strip 20 also moves. Since the camarm 94 is attached to the holder 90 and the blade 112 of the cam arm 94is secured to the lancet 30, the lancet 30 extends along with the restof the integrated lancing test strip 20 towards the body part 134. Oncethe test strip 20 contacts the body part 134, the frictional forces thatcaused the test strip 26 to move with the holder 90 are unable to movethe test strip 26 any further so that the test strip 26 rests againstthe tissue 134. Although the test strip 26 stops moving, the lancet 30continues to move because of the engagement of the lancet 30 with thecam arm 94 of the still moving holder 90. Consequently, upon contactingthe tissue 134, the test strip 26 is pushed back, and the tip 38 of thelancet 30 is exposed such that the tip 38 penetrates the tissue 134, asis depicted in FIG. 17. As indicated by direction arrow 135 in FIG. 17,the lancet 30 continues to extend until the firing mechanism 63 reachesits maximum stroke length. After forming an incision 136 in the tissue134, the firing mechanism 63 retracts the holder 90, which in turnretracts the lancet 30 as well as the rest of the integrated lancingtest strip 20. In another embodiment, the test strip 26 does not contactthe skin during lancing, but rather, the tip 38 of the lancet is exposedby contacting the backside of the expression member 72.

As mentioned previously, the adjustment control 66 via the stop 122controls the position of the test strip 26 relative to the tissue 134 soas to prevent constriction of fluid flow from the incision 136. Duringretraction of the holder 90, the integrated lancing test strip 20 alongwith the connector block 102 retract until the connector block 102contacts the stop 122, thereby limiting the retraction of the test strip26. Although the test strip 26 stops retracting, the cam arm 94 alongwith the lancet 30 continues to retract in direction 130, as is shown inFIG. 18, such that the lancet 30 retracts inside the guide slot 31 ofthe lancet assembly 22. Once retracted, the lancet 30 can be receivedinside the sterility sheet 24 so as to reduce the risk of accidentalinjury as well as biological contaminate exposure during disposal. Inone form, the sterility sheet 24 can act like wiper blades so as to wipebody fluid 138 or other contaminants from the lancet 30 so that theintegrated lancing test strip 20 is generally cleaner after use as wellas increase the amount of body fluid 138 that is available for testing.In one example, the sterility sheet 24 is hydrophobic to enhance theability to wipe body fluid 138 from the lancet 30.

Looking at FIG. 18, the edge of the test strip 26 is spaced slightlyaway from the surface of the tissue 134, but is still positioned closeenough to collect the body fluid 138 from the incision 136. It should benoted that the user can twist the adjustment control 66 so that theintegrated lancing test strip 20 lightly contacts the tissue 134 duringsampling or space the test strip 26 farther away, if so desired.Moreover, it is envisioned that other components, such as bendablewicking flags and the like, can also contact the skin during sampling.The lancet 30 is recessed behind capillary opening 49 so the lancet 30does not contact the tissue 134 when the lancet 30 is retracted and isfar enough behind capillary opening 49 so the drop of body fluid 138will find the capillary opening 49 of the test strip 26 before the bodyfluid 138 finds the opening formed by the lancet 30 in the sterilitysheet 24. For instance, the lancet 30 in one embodiment is retracted 0.5to 0.75 mm behind the capillary opening 49. By recessing the lancetpackage 44 in the manner illustrated, expression of body fluid 138 fromthe incision 136 is not hindered by the presence of the lancet 30. Ifneeded, the user can press the meter 30 against the tissue 134 such thatthe expression member 72 expresses the body fluid 138 from the incision136. Once the body fluid 138 starts flowing from the incision 134, thecapillary channel 49 of the test strip 26 collects the fluid 138. Aspreviously noted, the test strip 26 has the notch 50 that directs thefluid flow towards the opening 39 of the capillary channel 49 and awayfrom the lancet 30.

After a sufficient amount of the body fluid 138 is collected, the fluid138 is analyzed with the test strip 26, and the test results are shownon a display on the meter 60 and/or transmitted to another device, likea computer for further analysis. Once the integrated lancing test strip20 has been used, the integrated strip 20 is removed from the meter 60for disposal. During removal of the integrated lancing test strip 20,the cap 62 is pivoted out of the way to allow the user to gain access tothe integrated lancing test strip 20, as is depicted in FIG. 9. Toremove the integrated strip 20, the user pulls the integrated strip 20out of the meter 60. With reference to FIG. 13, as the user pulls theintegrated strip 20, the hooked or angled shape of the blade 112 causethe pivot arm 94 to rotate away from the integrated lancing test strip20. This rotational movement causes the cam arm 94 to disengage from thedetent mechanism 114, thereby allowing the cam arm 94 to rotate freely.When the integrated lancing test strip 20 is pulled further, the cam arm94 continues to rotate until the blade 112 disengages from theengagement notch 39 in the lancet 30. With the integrated lancing teststrip 20 disengaged from the cam arm 94, the integrated strip 20 canthen be completely removed from the meter 60 for disposal or furtheranalysis, if so desired. For subsequent tests, new integrated lancingtest strips 20 can then be loaded into the meter 60 in the manner as wasdescribe above.

From the previous discussion, it should be appreciated that theintegrated lancing test strip 20 as well as the meter 60 can be used tosample and analyze body fluid from various body parts like fingers andalternate sites, such as the forearm, for example. Moreover, theintegrated lancing test strip 20 can be used to analyze numerous typesof body fluids, such as interstitial fluid and blood, to name a few. Italso should be recognized that the features of the integrated lancingtest strip 20 can be modified for use in other types of meters besidesthe one illustrated in the drawings. Conversely, the above-describedmeter 60 can be used in conjunction with other types of samplingdevices, besides the above-described integrated lancing test strip 20.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected. All publications, patents and patentapplications cited in this specification are herein incorporated byreference as if each individual publication, patent or patentapplication was specifically and individually indicated to beincorporated by reference as set forth in its entirety herein.

1. A method, comprising: creating a lancet packet by enclosing a lancetin a sterility sheet to form a sterile enclosure; sterilizing thelancet; and assembling an integrated lancing test strip by attaching thelancet packet to a test strip after said sterilizing the lancet.
 2. Themethod of claim 1, wherein said sterilizing occurs after said creatingthe lancet packet.
 3. The method of claim 1, wherein said sterilizingoccurs before said creating the lancet packet.
 4. The method of claim 1,wherein said creating the lancet packet includes: providing a belt thatincludes a plurality of the lancets; and sandwiching the belt betweenthe sterility sheet by the folding the sterility sheet around the belt.5. The method of claim 4, further comprising cutting the integratedlancing test strip from the belt.
 6. The method of claim 1, furthercomprising: creating an engagement opening in the lancet; creating arelief notch in the test strip; and wherein said assembling theintegrated lancing test strip includes aligning the engagement openingof the lancet with the relief notch of the test strip.
 7. The method ofclaim 1, wherein said creating the lancet packet includes: locating thelancet inside a guide slot of a guide member, wherein the guide slot hasa guide slot opening, folding the sterility sheet to form two flaps witha crease in between, and enclosing the guide slot of the guide member bysandwiching the guide member between the flaps.
 8. The method of claim1, further comprising: creating a capillary opening in the test strip inwhich the body fluid is drawn; and positioning a notch in the test stripproximal the lancet packet to direct flow of the body fluid away fromthe lancet.
 9. The method of claim 1, further comprising: wherein boththe lancet packet and the test strip are generally flat; and whereinsaid assembling the integrated lancing test strip includes sandwichingthe lancet packet and the test strip together to create a compactconfiguration.
 10. The method of claim 1, further comprising treatingthe sterility sheet so that at least a part of the sterility sheet ishydrophobic.
 11. The method of claim 1, further comprising: creating aguide member with a guide slot that has one or more end stops to retainthe lancet in the lancet packet; and sealing the guide member in thelancet packet with the lancet disposed inside the guide slot.
 12. Themethod of claim 1, creating a capillary channel opening in the teststrip where body fluid enters the test strip; and wherein saidassembling the integrated lancing test strip includes locating the teststrip at a position where the lancet extends proximal the capillarychannel opening.
 13. The method of claim 12, further comprising: whereinthe packet has an end edge where the lancet pierces the packet; andpositioning the end edge of the packet is recessed away from thecapillary channel opening to promote flow of the body fluid to thecapillary channel opening.
 14. The method of claim 1, wherein the teststrip is an electrochemical test strip.
 15. The method of claim 1,further comprising: treating the sterility sheet so that at least a partof the sterility sheet is hydrophobic; wherein said sterilizing occursafter said creating the lancet packet; wherein said creating the lancetpacket includes providing a belt that includes a plurality of thelancets, locating the lancet inside a guide slot of a guide member,wherein the guide slot has a guide slot opening and one or more endstops to retain the lancet in the lancet packet, locating the test stripat a position where the lancet extends proximal a capillary channelopening of the test strip, sandwiching the belt between the sterilitysheet by the folding the sterility sheet around the belt to form twoflaps with a crease in between, enclosing the guide slot of the guidemember by sandwiching the guide member between the flaps, and cuttingthe integrated lancing test strip from the belt; creating a capillaryopening in the test strip in which the body fluid is drawn; positioninga notch in the test strip proximal the lancet packet to direct flow ofthe body fluid away from the lancet; wherein both the lancet packet andthe test strip are generally flat; wherein the packet has an end edgewhere the lancet pierces the packet; positioning the end edge of thepacket is recessed away from the capillary channel opening to promoteflow of the body fluid to the capillary channel opening; and wherein thetest strip is an electrochemical test strip.